Method for performing a gastrectomy

ABSTRACT

A method for performing a gastrectomy (stomach reduction surgery).

This application is a continuation of U.S. application Ser. No.14/009,842, filed Oct. 4, 2013, which is pending, which is a nationalstage of PCT Application PCT/US2012/032138, filed Apr. 4, 2012, whichclaims priority to U.S. provisional application 61/471,454, filed onApr. 4, 2011.

BACKGROUND OF THE INVENTION

The present invention pertains to an apparatus that is positioned in ahollow viscus organ and functions as a template for creating a lumen ofa desired shape and size in the organ from the tissue of the organ, andthe method of using the apparatus in creating the lumen.

SUMMARY

The apparatus of the invention is employed in creating a lumen of adesired shape and size in a hollow viscus organ from tissue of theorgan. In particular, the present invention is employed in creating atubular gastric sleeve from the tissue of a patient's stomach.

The apparatus is comprised of an elongate, flexible tube having oppositeproximal and distal ends. The tube has several lumens or pathways thatextend through the interior of the tube between the proximal and distalends of the tube.

A directional, steerable feature extends through one of the lumens ofthe tube. The directional, steerable feature is manually operable at thetube proximal end to direct and steer the tube distal end in differentdirections relative to the length of the tube.

An anchor feature is provided at the tube distal end and is manuallyoperable from the tube proximal end. The anchor feature selectivelyanchors or secures the tube distal end to tissue of a hollow viscusorgan. In particular, the anchor feature can be selectively operated tosecure the tube distal end in the beginning of the small intestine orduodenum of a patient.

An exterior surface dimension adjustable feature is provided adjacentthe tube distal end. The adjustable feature is also manually operable atthe tube proximal end. The adjustable feature can be selectivelyenlarged and reduced in shape configuration and circumferentialdimensions. When enlarged, the exterior surface of the adjustablefeature has its largest circumferential dimension at the end of theadjustable feature that is adjacent the tube distal end. From this endof the enlarged adjustable feature the circumferential dimension of thefeature gradually decreases as the adjustable feature extends toward thetube proximal end.

A suction communication feature is provided along at least a portion ofthe tube length. The suction feature is also operable at the tubeproximal end. Manual operation of the suction feature supplies suctionpressure along at least a portion of the tube length that draws thetissue of the hollow viscus organ toward the exterior surface of thetube.

In use of the apparatus the tube distal end is first inserted throughthe patient's esophagus and then into the patient's stomach. The anchorfeature at the tube distal end is guided from the stomach interior pastthe patient's pyloric valve and into the beginning of the smallintestine or duodenum. The anchor feature is then operated to secure thetube distal end in its position. The length of the tube is then manuallypulled from the proximal end to position the tube, and in particular theexterior surface dimension adjustable feature along the lesser curvatureof the stomach and adjacent the stomach incisura. The exterior surfacedimension adjustable feature is then enlarged. The suction communicationfeature is then operated, causing portions of the stomach wall to bedrawn to and wrapped around the exterior surface dimension adjustablefeature. The position of the adjustable feature along the stomach lessercurvature is then demarcated on the stomach exterior. Opposing portionsof the stomach wall are then affixed together along the side portion ofthe enlarged dimension adjustable feature that is opposite the stomachlesser curvature, thereby creating a tubular gastric sleeve from thepatient's stomach. The exterior surface dimension adjustable feature isthen reduced in size, and the anchor feature is disengaged from thestomach. The apparatus is then removed from the patient's stomachleaving the gastric sleeve. The gastric sleeve will then function as anew gastric reservoir with an interior configuration that is without anysignificant, limiting constriction in the sleeve interior configurationin the area of the stomach incisura or other tenuous area of thereservoir after the apparatus has been removed.

DESCRIPTION OF THE DRAWINGS

Further features of the apparatus and its method of use are set forth inthe following detailed description of the apparatus and method and inthe drawing figures.

FIG. 1 is a representation of one embodiment of the apparatus of theinvention.

FIG. 2 is a representation of the apparatus being inserted into a hollowviscus organ with the stomach being shown as one example of a hollowviscus organ.

FIG. 3 is a representation of the apparatus being anchored to stomachtissue.

FIG. 4 is a representation of the apparatus being positioned against thelesser curvature of the stomach wall.

FIG. 5 is a representation of the apparatus in which a portion of theapparatus exterior surface has had its circumferential dimensionincreased.

FIG. 6 is a representation of the apparatus functioning as a template increating a lumen of a desired shape and size in a hollow viscus organfrom the tissue of the organ, i.e., in the stomach from the tissue ofthe stomach.

FIG. 7 is a representation of the apparatus after the lumen of thedesired shape and size has been created in the stomach and the apparatusis being removed from the stomach.

DESCRIPTION OF THE APPARATUS OF THE INVENTION AND ITS METHOD OF USE

The apparatus of the invention 12 is designed for use in surgicalprocedures in creating a lumen of a desired shape and size in a hollowviscus organ from the tissue of the organ. In one example of the methodof using the apparatus disclosed herein, the apparatus is designed to beintroduced through the esophagus of a human patient and into thepatient's stomach. The apparatus if then positioned along the lessercurvature of the stomach and is used as a template or guide in creatinga lumen of a desired shape and size in the stomach from stomach tissuewrapped around the apparatus. The apparatus 12 is therefore constructedof biocompatible materials typically employed in the constructions ofsurgery devices.

Although the apparatus 12 of the invention and its method of use aredescribed herein as creating a lumen of a desired shape and size in thestomach from the tissue of the stomach, it should be understood that theapparatus 12 of the invention is designed to be used as a template orguide in creating a lumen of a desired shape and size in a hollow viscusorgan, not necessarily the stomach.

The apparatus 12 is basically constructed as a bougie having an elongateflexible, tube 14 with opposite proximal 16 and distal 18 ends. Aplurality of separate bores or lumens represented by dashed lines 20 inFIG. 1 extend through the interior of the tube 14 from the tube proximalend 16 toward the tube distal end 18. The lumens provide separate pathsof communication through the interior of the tube 14 that communicate aplurality of manually operable controls 22 at the tube proximal end 16with a plurality of features of the apparatus 12 that are positionedalong portions of the tube length adjacent the tube distal end 18.

The extreme distal end of the apparatus tube length is formed as a blunttip 26 having a smooth exterior surface. This enables the distal end tip26 to easily pass over or through body tissue without causing damage tothe tissue. If desired, an illumination light and/or endoscope opening28 could be provided in the distal end tip 26 of the tube. The lightand/or endoscope would be connected by any known appropriatecommunication means through one of the lumens 20 extending through thelength of the tube 14 with a manually operable control 32 provided forthe light or endoscope at the tube 14 proximal end 16. In this manner,illumination light could be provided at the tube distal end tip 26. Thisenables the location of the tip 26 in the stomach to be identifiedthrough the stomach wall from the abdominal cavity. Additionally, anendoscope visual image could be provided at the tube distal end tip.

The apparatus tube 14 is also provided with a directional or steerablefeature that extends from the distal end 18 through one of the lumens 20to a manually operable control 36 of the feature at the tube proximalend 16. Any conventional or known directional or steerable feature couldbe employed in the construction of the apparatus 12 for this purpose.The directional/steerable feature would be operable at the proximal end16 of the tube 14 to direct and steer the distal end 18 of the tube indifferent directions relative to the length of the tube 14. Examples ofknown directional/steerable features include those that employ wiresthat extend along different sides of the tube length that are pulled intension to curve and direct the different sides of the tube length.Additionally, shape memory wires or other equivalent means could beemployed as the directional/steerable feature of the apparatus 12.

The apparatus 12 is also provided with an anchor feature 42 at the tubedistal end 18. In the embodiment of the apparatus 12 shown in FIG. 1,the anchor feature 42 is an inflatable balloon that communicates throughone of the lumens 20 with a control 44 at the tube proximal end 16. Theballoon anchor feature 42 is shown in solid lines in its deflatedcondition in FIG. 1, and in dashed lines in its inflated condition inFIG. 1. The manually operable control 44 provided at the tube lengthproximal end 16 controls the selective inflation and deflation of theballoon 42. In its deflated condition the balloon 42 is dimensioned toenable it to be inserted through the esophagus and into the stomachinterior and from the stomach interior past the pyloric valve orsphincter and into the beginning of the small intestine or duodenum.With the balloon 42 so positioned, inflating the balloon 42 anchors thedistal end portion 18 of the apparatus 12 in the duodenum. In thismanner, the apparatus distal end 18 is securely anchored to the stomachtissue. In addition, the anchor feature 42 could be provided with anilluminating light that is controllable at the manual control 44. Theanchor feature light would enable identifying the location of the anchorfeature inside the stomach by viewing the light through the stomach wellfrom inside the abdominal cavity.

In different embodiments of the apparatus 12, the balloon anchor feature42 could be replaced with other equivalent types of anchors. Forexample, the balloon anchor feature 24 could be replaced withselectively extendable hooks or prongs 48 shown in dash lines in FIG. 1that would also function to anchor the apparatus distal end 18 to thestomach tissue.

An exterior surface dimension adjustable feature 52 is also provided onthe apparatus 12 along a portion of the tube 14. As shown in FIG. 1, theexterior surface adjustable feature 52 extends completely around thetube and along a significant portion of the tube 14 length adjacent thedistal end 19 of the tube, but is spaced along the tube length and isseparate from the anchor feature 42. The exterior surface adjustablefeature 52 communicates through one of the lumens 20 with a manualcontrol 54 provided for the feature at the tube proximal end 16. Thecontrol 54 is manually operated to selectively move the adjustablefeature 52 between a retracted condition shown in solid lines in FIG. 1and an extended or enlarged condition shown in dashed lines in FIG. 1.In the retracted condition the circumferential dimension of theadjustable feature 52 enables insertion of the feature through theesophagus of a patient and into the stomach of the patient. Whenmanually operated to move to its enlarged condition in dashed lines inFIG. 1, the exterior surface 56 of the adjustable feature 52 has a shapeconfiguration and circumferential dimensions along the length of thefeature that enable it to be used as a template in creating a lumen of adesired shape and size in a hollow viscus organ from the tissue of theorgan. In the example of FIG. 1, the adjustable feature 52 is used as atemplate for creating a lumen of a desired shape and size in the stomachtissue surrounding the adjustable feature 52 in performing the desiredmethod of the invention that will be later described. One example of thedesired shape configuration and circumferential dimensions of theexterior surface 56 of the adjustable feature 52 in its enlargedcondition is shown in dashed lines in FIG. 1. The adjustable feature hasa generally annular cross-section configuration defined by the circularcross-section of the tube 14 at its center and the exterior surface 56of the adjustable feature 52. The exterior surface 56 extends around aninterior volume of the adjustable feature 52 with the tube 14 at thecenter of the volume. The length of the adjustable feature 52 extendsfrom a proximal end 58 of the exterior surface 56 to a distal end 60 ofthe exterior surface. As seen in FIG. 1, the circumferential dimensionof the enlarged exterior surface 56 increases as it extends fromadjacent the proximal end 58 to adjacent the distal end 60. It should beunderstood that the exterior surface adjustable feature 52 in itsenlarged condition could have other desired shape configurations andsize dimensions depending on its intended use. As shown in FIG. 1, theexterior surface circumferential dimensions of the enlarged feature 52are largest toward the distal end 18 of the tube 14. The exteriorsurface circumferential dimensions of the enlarged feature 52 graduallybecome smaller as the adjustable feature 52 extends along the portion ofthe tube length toward the proximal end 16 of the tube 14.

An example of an exterior surface adjustable feature 52 that could beemployed on the apparatus 12 is an inflatable balloon having a desiredexterior configuration with desired circumferential dimensions when inthe enlarged or inflated condition of the balloon, and when deflated theballoon returns to the retracted condition of the feature 52 representedby the solid lines in FIG. 1. The adjustable feature would communicatethrough one of the lumens 20 through the tube to a manual control 54 toselectively inflate and deflate the adjustable feature 52. As analternative to an inflatable balloon, the exterior surface adjustablefeature 52 could be a mechanical linkage system that enlarges andretracts in the same manner as an inflatable balloon, or otherequivalent means of performing the functions of the exterior surfaceadjustable feature 52.

The apparatus of the invention 12 is also provided with a suctionpressure communication feature 62 that communicates through one of thelumens 20 with a manual control 64. The suction feature 62 enablessuction pressure to be delivered to a portion or portions of theapparatus tube 14 length in response to the manual operation of thecontrol 64 at the tube proximal end 16. FIG. 1 shows suction holes 62provided in portions of the apparatus tube 14 length that function asthe suction pressure communication feature 62. The holes 62 deliversuction pressure to the exterior surface of the tube 14 length in theareas of the holes 62. In other examples of the apparatus 12, the holes62 could be replaced by slits in the exterior surface of the tube lengthor other equivalent means of delivering suction pressure to desiredareas of the exterior surface of a tube length. The suction pressuredelivered to the holes 62 by manual operation of the control 64 causesthe stomach or other hollow viscus organ to contract around theapparatus in the areas of the holes. The portions of the stomach tissueor organ tissue are drawn or wrapped around the exterior surface of theadjustable feature 52 and around the portions of the apparatus tubelength having the suction holes 62.

The use of the apparatus of the invention 12 according to the method ofthe invention is shown in the drawing FIGS. 2-7. In FIGS. 2-7 theapparatus 12 is shown being used as a template or guide in creating alumen of a desired shape and size in the stomach from the tissue of thestomach. It should be understood that this is only one example of a useof the apparatus and the apparatus is not limited to use in the stomach.The apparatus of the invention 12 is designed to be used as a templateor guide for creating a lumen of a desired shape and size in a hollowviscus organ (not necessarily the stomach) from the tissue of the organ.

FIG. 2 shows the apparatus 12 being inserted distal end 18 first throughthe patient's esophagus 72 and into the interior 74 of the patient'sstomach 76. As the apparatus 12 is moved through the stomach interior 74by manually operating the steerable feature control 36, the apparatusdistal end 18 is directed toward the pylorus 78 and is inserted throughthe pyloric valve 82. The illumination light and/or endoscope 28 may beemployed in directing the apparatus distal end 18 through the valve.Additionally, the illuminating light of the anchor feature 42 may beused in identifying the location of the apparatus distal end 18 insidethe stomach by viewing the light through the stomach wall from theabdominal cavity.

With the apparatus distal end 18 inserted through the pyloric valve 82and position in the pylorus 78, the anchor feature control 44 is thenmanually operated to cause the anchor feature 42 to secure the apparatusdistal end 18 to the stomach tissue. FIG. 3 shows the balloon anchorfeature 42 being inflated in the pylorus 78 and thereby securing theapparatus distal end 18 to the stomach tissue in the pylorus 78.

The tube 14 of the apparatus 12 is then manipulated from the apparatusproximal end 16 to position a portion of the tube length and inparticular to position the external surface adjustment feature 52against the lesser curvature wall 84 of the stomach 76 as shown in FIG.4. With the exterior surface adjustment feature 52 so positioned, thecontrol 54 for the feature 52 is then manually operated to cause thefeature 52 to enlarge to its desired shape configuration andcircumferential dimensions as shown in FIG. 5.

The suction pressure feature 62 of the apparatus 12 is then activated bymanual operation of its associated control 64. This evacuates thestomach interior 74 through the suction pressure feature 62 and causesthe stomach to contract around the apparatus and in particular aroundthe exterior surface adjustment feature 52. The contraction of thestomach causes portions of the stomach tissue along the stomach lessercurvature 84 to wrap around and envelop the exterior surface adjustmentfeature 52. With portions of the stomach wall along the lesser curvature84 wrapped over the exterior surface adjustment feature 52, the templateconfiguration of the exterior surface adjustment feature 52 isdemarcated on the stomach wall outside the stomach, making it easier todiscern the position of the exterior surface adjustment feature 52 fromoutside the stomach.

Opposing portions of the stomach wall are then affixed 86 together alongthe side of the exterior surface adjustment feature 52 that is oppositethe stomach lesser curvature 84. The opposing portions of the stomachwall can be affixed 86 together by conventional means such as stapling,suturing, etc. Plication could also be used to reduce the size of thestomach and secure the opposing portions of the stomach wall togetheralong the side of the exterior surface adjustment feature 52 that isopposite the stomach lesser curvature 84. This creates a lumen 88 of adesired shape and size in the stomach from the opposing portions of thestomach wall wrapped around the exterior surface adjustment feature 52.The lumen 88 created has an interior configuration of a desired shapeand size that conforms to the shape configuration and thecircumferential size dimensions of the exterior surface adjustmentfeature 52 inside the just created lumen 88. Due to the shape of theadjustment feature 52 and in particular the circumferential dimension ofthe adjustment feature 52 being larger adjacent the tube distal end 18and becoming smaller as it extends toward the tube proximal end 16, theinterior configuration of the lumen 88 created is without anysignificant, limiting constriction in the lumen interior in the area ofthe stomach incisura or other tenuous area of the lumen interior.

With the lumen 88 created, the exterior surface adjustment feature 52 iscontrolled by its associated control 54 to return to its retractedcondition on the apparatus tube 14 as shown in FIG. 6. The anchorfeature 42 is also controlled by its associated control 44 to disengagefrom the stomach tissue as shown in FIG. 7. The apparatus 12 can then beremoved from the lumen 88. The lumen 88 then functions as a new gastricreservoir with an interior configuration that is without anysignificant, limiting constriction in the interior configuration of thelumen 88 in the area of the stomach incisura 92 or other tenuousinterior area of the created lumen 88 after the apparatus 12 has beenremoved.

We claim:
 1. A method of creating a lumen of a desired shape and size ina hollow viscus organ of a patient from tissue of the organ, the methodcomprising: providing a template having a flexible tube length withopposite proximal and distal ends; inserting the template distal endfirst into the patient's hollow viscus organ; positioning a portion ofthe template length against an interior wall of the organ; demarcatingthe template's configuration so as to make it easily discernible fromoutside the organ; affixing together opposing portions of the organwall, along a side of the portion of the template length that isopposite the portion of the template length positioned against the organinterior wall, thereby creating a lumen of a desired shape and size inthe organ from the tissue of the organ, the lumen having an interiorconfiguration that conforms to the portion of the template length within the portion of the organ wall; removing the template from the lumenwhereby the lumen has an interior configuration that is without anysignificant, limiting constriction in the lumen interior configurationor other tenuous area of the lumen interior after the template has beenremoved.
 2. The method of claim 1, further comprising: creating thelumen as a tubular gastric sleeve from the patient's stomach.
 3. Themethod of claim 2, further comprising: inserting the template distal endfirst through the esophagus of the patient and then into the patient'sstomach.
 4. The method of claim 3, further comprising: positioning theportion of the template length against the patient's stomach wall, alongthe stomach lesser curvature.
 5. The method of claim 4, furthercomprising: affixing together opposing portions of the stomach wall,along a side of the portion of the template length that is opposite thestomach lesser curvature, thereby creating the lumen as a tubular sleeveof the stomach having an interior configuration that conforms to theportion of the template length within the portion of the stomach wall.6. The method of claim 5, further comprising: removing the template fromthe gastric sleeve whereby the sleeve will function as a new gastricreservoir with an interior configuration that is without anysignificant, limiting constriction in the sleeve interior configurationin the area of the stomach incisura or other tenuous area of thereservoir after the template has been removed.
 7. The method of claim 1,further comprising: enlarging a portion of an exterior surface of thetemplate before demarcating the template's configuration.
 8. The methodof claim 7, further comprising: enlarging the portion of the exteriorsurface of the template with the enlarged portion of the exteriorsurface having a larger circumferential dimension adjacent the templatedistal end and the circumferential dimension of the enlarged portion ofthe exterior surface becoming smaller as it extends toward the templateproximal end.
 9. A method of reducing the size of the stomach of apatient, said method comprising the steps of: providing a tube having adistal end and a proximal end, with said distal end adapted forinsertion into the stomach of the patient; inserting the distal end ofthe tube through the patient's esophagus and then into the patient'sstomach, and disposing the tube along a lesser curve of the stomach;drawing the stomach toward the tube; with the tube disposed within thestomach, and the stomach drawn toward the tube, affixing opposing wallsof the stomach along the tube, opposite the lesser curve; withdrawingthe tube from the stomach.
 10. The method of claim 9, further comprisingthe steps of: drawing the stomach toward the tube by applying suction tothe stomach through apertures in the distal end of the tube.
 11. Themethod of claim 9, further comprising the steps of: prior to drawingstomach toward the tube, anchoring a portion of the distal end of thetube in the pyloric valve of the patient.
 12. The method of claim 9,further comprising the steps of: providing a balloon about the distalend of the tube; and inserting the distal end of the tube through intothe patient's stomach such that the balloon is proximate the lessercurve, and inflating the balloon prior to drawing the stomach toward thetube.
 13. The method of claim 9, further comprising the steps of: usingthe tube as a guide, after the stomach has been drawn toward the tube,marking the stomach along a line proximate the tube, opposite the lessercurve; performing the affixing step by affixing opposing walls of thestomach along the marked line.